(a) The purpose of the central cancer registry is to
receive and to compile, tabulate, and preserve statistical, clinical, and other
reports and records relating to the incidence, treatment and cure of cancer,
and to provide assistance and consultation for public health work. The
statistical reports and records, and the assistance rendered to health care
facilities, health planning agencies and research facilities are intended to
improve cancer treatment, extend the life of the cancer patient, identify high
risk groups or areas of the state and attempt to lower the morbidity and
mortality of cancer in North Carolina.

(b) The central cancer registry is administered by State
Center for Health Statistics, Division of Public Health, North Carolina
Department of Health and Human Services, 1908 Mail Service Center,
Raleigh, North Carolina 27699-1908.

History Note: Authority G.S. 130A‑205; 130A-208
through 130A-213;

Eff. January 1, 1982;

Amended Eff. July
1, 1985;

Transferred and Recodified from 10 NCAC 8A .0801 Eff. April
4, 1990;

Amended Eff. April
1, 2001; December 1, 1990;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.

10A NCAC 47B .0102 DEFINITIONS

The following definitions shall apply throughout this
Section:

(1) "Abstract" refers to a document or
documents, including electronic documents and files, containing information
drawn from a cancer patient's medical record.

(2) "Cancer registrar" is a registrar who
abstracts information from the medical records of cancer patients.

(3) "Death
match" refers to the procedure of comparing registry cases with death
certificate information, for confirmation of the reported death of any cancer
patient, to determine if the cancer constituted the cause of death, and for
identification of cases missed in routine reporting procedures.

(4) "Definitive
treatment" refers to all methods of treatment intended to modify or
control the cancer including no treatment, palliative care, and follow-up care.

(5) "Follow‑up
information" is information on the post-treatment status of a cancer
patient whose abstract was submitted to the registry previously.

(6) "Identifying
information" is any portion of any abstract that might reveal the personal
identity of a cancer patient.

(8) "Palliative treatment" refers to
treatment that is not intended to effect a cure, but the treatment procedure is
expected to improve "quality of life" by temporarily relieving
distressing symptoms.

(9) "Participating facility" is a health care
facility that submits abstracts to the registry.

(10) "Pathology
report" is the written report generated by a pathologist, stating the
diagnostic interpretation of tissue samples or cellular material examined by
the pathologist.

(11) "Personnel"
means persons who are employees of the Department of Health and Human Services,
or who are persons who provide services to the central cancer registry through
a written contract.

(12) "Positive
pathology report" is a pathology report confirming the presence of cancer.

(13) "Registrar"
is an employee of a health care facility who prepares abstracts of medical
records.

(14) "Registry"
is the central cancer registry. The registry is administratively assigned to
the State Center for Health Statistics, Department of Health and Human
Services.

(15) "Statistical
report" refers to a report generated by the registry for informational or
educational purposes. A statistical report contains aggregated data and does
not contain identifying information.

History Note: Authority G.S. 130A‑205; 130A-208
through 130A-213;

Eff. January 1, 1982;

Amended Eff. October
1, 1983;

Transferred and Recodified from 10 NCAC 8A .0802 Eff. April
4, 1990;

Amended Eff. April
1, 2001; December 1, 1990;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.

10A NCAC 47B .0103 CONFIDENTIALITY

(a) The clinical records of individual patients submitted
to the registry shall be confidential and shall not be public records open to
inspection. Only personnel authorized by the director of the State Center for Health
Statistics and other individuals authorized by the director of the State Center
for Health Statistics or his/her designee pursuant to Paragraph (c) of this
Rule shall have access to the records.

(b) The information contained in the clinical records of
individual patients submitted to the registry may be transferred to computer‑compatible
means of data entry. Only personnel authorized by the director of the State
Center for Health Statistics to use computers, terminals, programs, data
files, and other computer hardware or software involved in maintaining patient
information shall have access to them.

(c) Clinical information in possession of the registry may
be disclosed in the following circumstances when authorized by the director of
the State Center for Health Statistics or his/her designee:

(1) A patient shall have access to review or
obtain copies of his/her records;

(2) Information may be disclosed in response to
a valid court order;

(3) Information may be disclosed as provided in
Rule .0106 of this Section;

(4) Information contained in death certificates
on file with the division (but not actual copies of death certificates) may be
released to a participating facility when the facility requests a death match
for confirmation of the reported or suspected deaths of cancer patients treated
at that facility. Death match information released by the registry shall
include only that information contained in the death certificates.

(d) The State Center for Health Statistics may release
statistical information and data based on client information so long as no
information identifying individual patients is released.

(e) Photocopying or other reproduction of any clinical
records or reports containing identifying information, except as may be
required in the conduct of the official business of the registry, is
prohibited.

(f) Any legible documents other than the original
abstracts, such as computer printouts or photocopies of any documents
containing identifying information, shall also be considered confidential
material while in active use, and shall be destroyed immediately upon
termination of their use by the registry.

(g) Original
copies of reports and abstracts, and follow‑up information received
thereunto, shall be retained for 5 years by the registry.

(h) The director
of the State Center for Health Statistics shall make known to all individuals
with access to patient information submitted to the registry the privileged and
confidential nature of such information.

History Note: Authority G.S. 130A‑205; 130A-208
through 130A-213;

Eff. January 1, 1982;

Amended Eff. October
1, 1982;

Transferred and Recodified from 10 NCAC 8A .0803 Eff. April
4, 1990;

Amended Eff. April
1, 2001; December 1, 1990;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.

10A NCAC 47B .0104 REPORTING OF CANCER

(a) Health care facilities and providers shall submit a
complete abstract for each cancer case that is screened, diagnosed, treated, or
followed by its staff and that was initially diagnosed with cancer subsequent
to May 7, 1999. A complete abstract is defined as one that adheres to the
standards and definitions of the North American Association of Central Cancer
Registries (NAACCR), the World Health Organization (WHO), the American
College of Surgeons Commission on Cancer (COC), and the National Cancer Institute
Surveillance, Epidemiology, and End Results Program (SEER). These standards
and definitions are delineated in the following publications: the NAACCR Standards
for Cancer Registries, the WHO International Classification of Diseases
for Oncology; the COC Standards of the Commission on Cancer, Volume II,
Registry Operations and Data Standards (ROADS); and the SEER Coding
Manuals. Subsequent amendments and editions of these publications are
included. NAACCR documents are free of charge and may be obtained from the
North American Association of Central Cancer Registries, 2121 West White Oaks
Drive, Springfield, Illinois 62704. The International Classification of
Diseases for Oncology may be purchased for twenty-seven dollars ($27.00)
from WHO Publications Center USA, 49 Sheridan Avenue, New York, NY
12210. The ROADS publication may be purchased for twenty dollars
($20.00) from ACS Publications Fulfillment Section, Box 92425, Chicago, IL
60675-2425. SEER publications are free of charge and may be obtained from the
National Cancer Institute, Publications Ordering Service, P.O. Box 24128, Baltimore, MD 21227.

(b) A health care provider or facility may delegate the
tasks of reporting cancer cases to office or hospital staff, but the provider
or facility shall not delegate the legal responsibility for the reporting of
cancer to others.

(c) A report of cancer shall be submitted to the registry
by health care facilities and providers by one of the following methods:

(1) by submission of an electronic file
containing the information required in Paragraph (a) of this Rule;

(2) for pathology laboratories, by submission
of a positive electronic pathology report containing the information required
in Paragraph (a) of this Rule; or

(3) facilities or providers that have fewer
than 30 reportable cases per year may submit photocopies of the medical record
sufficient to complete a full abstract of the case.

(d) The following documents shall not constitute a report
of cancer:

(1) a death certificate; and

(2) a request for authorization submitted to
the Cancer program requesting third party reimbursement for treatment of
cancer, although a positive pathology report is required by 10 NCAC 8A
.0408(f).

(e) Reports shall be forwarded to the following address:
Central Cancer Registry, State Center for Health Statistics, 1908 Mail
Service Center, Raleigh, North Carolina 27699-1908.

History Note: Authority G.S. 130A‑205; 130A-208
through 130A-213;

Eff. January 1, 1982;

Amended Eff. October
1, 1984; October 1, 1982;

Transferred and Recodified from 10 NCAC 8A .0804 Eff. April
4, 1990;

Amended Eff. April
1, 2001; December 1, 1990;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.

(a) Any health care facility that is staffed and equipped
for the diagnosis, treatment or follow‑up care of cancer patients may
participate with the registry in the exchange of information regarding the
referral, treatment, maintenance or cure of cancer.

(b) The registry shall cooperate and consult with
participating health care facilities and providers to the end that cancer
registries in such facilities may provide the most accurate data available and
may otherwise operate in the best interest of the cancer patients being treated
therein. The registry will provide:

(1) Quality control reports to assure that
computerized data utilized for statistical information and data compilation are
correct;

(2) The
most accurate and effective treatment, survival and comparative information
available;

(3) Educational information available from
registry, morbidity and mortality statistics upon request of a professional
staff;

(4) Assistance to health care facilities by
providing appropriate data and consultation to help the facilities meet the
requirements for accreditation as a cancer treatment center, and to assist in
the maintenance of such accreditation;

(5) Confirmation
of the reported or presumed deaths (including such causes of deaths) of cancer
patients to assist health care facilities to more accurately assess patient
survival and to conduct more efficient long‑term follow‑up of
cancer patients;

(6) Other information for the purpose of
follow-up of a patient. This information is limited to the name of another
facility or physician providing services to the patient, the date of last
contact with the patient, and the vital status.

History Note: Authority G.S. 130A‑205; 130A-208
through 130A-213;

Eff. January 1, 1982;

Amended Eff. October
1, 1983; October 1, 1982;

Transferred and Recodified from 10 NCAC 8A .0805 Eff. April
4, 1990;

Amended Eff. April
1, 2001; December 1, 1990;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.

(a) The registry
may release statistical data to any person or agency for the following
purposes:

(1) medical research or education;

(2) epidemiological studies;

(3) health education;

(4) health planning or administration;

(5) required statistical reports; and

(6) other statistical reports by written
request for research, information or education.

(b) A researcher may request the release of medical records
from the registry by the submission of a written research proposal. This
request must adhere to the requirements pertaining to release of medical
records by the State Center for Health Statistics as defined by 10A NCAC 47A
.0102.

(c) The medical records or reports of the individual
patients may be disclosed to research staff for the purpose of medical
research, provided that the registry has determined that:

(1) disclosure of this information is deemed
necessary to accomplish the purposes of the research;

(2) the research warrants the risk to
individual patients of the potential disclosure of their medical records; and

(3) adequate safeguards to protect the medical
records or identifying information are established or maintained.

(d) The registry shall provide regular reports of research
activity and data released to the cancer committee of the North Carolina
Medical Society. Where there exists the potential for direct patient contact,
the registry shall consult with the chairman of the Committee on Cancer of the
North Carolina Medical Society before determining to release information for
research as provided in Paragraphs (b) and(c) of this Rule. The registry shall
forward the research proposal to the chairman for review. The chairman may
forward the proposal to any or all members of the committee for comment.

History Note: Authority G.S. 130A‑205; 130A-208
through 130A-213;

Eff. January 1, 1982;

Amended Eff. October 1, 1983;

Transferred and Recodified from 10 NCAC 8A .0806 Eff.
April 4, 1990;

Amended Eff. April 1, 2001;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.

10A Ncac 47B .0107 RESERVED FOR FUTURE CODIFICATION

10A NCAC 47B .0108 ASSISTANCE AND CONSULTATION FOR PUBLIC
HEALTH WORK

(a) The registry shall provide assistance and consultation
for public health work.

(b) The registry shall accept requests for assistance and
consultation for any agency, facility or organization actively engaged in the
effort to reduce the incidence of cancer, whether through direct service to or
the education of cancer patients and their families, the public, or the health
care professions.

(c) The registry may accept requests from students
requesting assistance with research projects in accordance with the provisions
of Rule .0106 of this Subchapter and the availability of staff time and
resources.

History Note: Authority G.S. 130A‑205;

Eff. January 1, 1982;

Transferred and Recodified from 10 NCAC 8A .0808 Eff. April
4, 1990;

Amended Eff April
1, 2001;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.

10A NCAC 47B .0109 FAILURE TO REPORT

(a) The registry shall monitor the reporting of health care
facilities and providers on a quarterly basis. If a health care facility or
provider has failed to report at least 90 percent of its cases within six
months of diagnosis, the registry shall notify the facility or provider in
writing of that fact within 30 days and the facility or provider shall be given
another 30 days, or up to 60 days for good cause shown, to fulfill its
reporting requirement.

(b) If a facility or provider is out of compliance for two
consecutive quarters and is not demonstrating progress toward becoming
compliant, then the State Health Director shall direct the registry to collect
the data and shall direct the facility or provider to reimburse the registry
for all actual costs expended in order to obtain the data up to one hundred
dollars ($100.00) per case abstracted. The amount of the reimbursement shall
include both travel expenses and the full cost of personnel time.

(c) Facilities or providers may request the director of the
registry for abstracting assistance at no cost to them. The decision as to what
assistance will be provided shall be based on the following:

(1) Size of the facility;

(2) Consistency of non-compliance;

(3) Staffing
of the registry;

(4) Duration
of needed assistance. The registry shall not provide long term abstracting
assistance to any facility that has greater than 100 cases per year;

(5) The potential for compromising the
registry's data quality; and

(6) Plans of the facility to reach compliance.

History Note: Authority G.S. 130A‑205; 130A-208
through 130A-213;

Eff. April 1, 2001;

Pursuant to G.S. 150B-21.3A, rule is necessary without
substantive public interest Eff. December 20, 2015.